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Ocular-vestibular Biomarker Identification for ADHD

Ocular-vestibular Biomarker Identification for ADHD

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04504890
Enrollment
240
Registered
2020-08-07
Start date
2020-07-16
Completion date
2021-10-05
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, ADHD - Combined Type, ADHD, Predominantly Hyperactive - Impulsive, ADHD Predominantly Inattentive Type

Keywords

ADHD, EYE-SYNC, eye tracking, oculomotor, vestibular

Brief summary

This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.

Detailed description

This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking paradigm) to dynamically capture the participants' attentional state. It will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by ADHD by examining the association between eye tracking performances and well-established standardized measures of ADHD.

Interventions

DEVICEEYE-SYNC

Nystagmograph used to measure eye movement

Sponsors

Sutter Health
CollaboratorOTHER
Sync-Think, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and women ages 6-70 seeking evaluation and treatment for ADHD.

Exclusion criteria

* Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition. * Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected Astigmatism. * Psychiatric history with any of the following: * LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder * LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder * Use of a psychotropic medication * Impairment of cranial nerves II-VI * Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. Subjects may not repeat participation

Design outcomes

Primary

MeasureTime frameDescription
Eye Tracking and ADHD measure correlationthrough study completion, an average of 1 yearZero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables
Eye Tracking ADHD Diagnostic ROCthrough study completion, an average of 1 yearSpecific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes
MANCOVA Eye Tracking in ADHD Treatment Populationthrough study completion, an average of 1 yearRepeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)

Countries

United States

Contacts

Primary ContactBenjamin Cheyette, M.D.,Ph.D.
cheyetbr@sutterhealth.org650.278.1814

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026